FDA Approves Pfizer/BioNTech's Bivalent COVID-19 Vaccine For Youngest Kids

Vandana Singh
1 min read
80
In this article:

  • The FDA has expanded the emergency use authorization (EUA) of Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) bivalent COVID-19 vaccine as a single booster dose in children under five years of age.

  • The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot.

  • Related: Pfizer/BioNTech Get Ready For London Court Battle With Moderna Over COVID-19 Vaccine Patents.

  • In December, the agency approved Pfizer/BioNTech's updated shot as a third dose for kids aged six months through four years who have not completed their primary vaccination series or are yet to receive the third dose.

  • The amended authorization is based on data from 60 children from the expanded age group, who completed primary vaccination with three doses, received a booster shot of Pfizer/BioNTech, and showed an immune response to both the original SARS-CoV-2 virus strain and Omicron BA.4/BA.5.

  • Last month, the companies submitted an FDA supplemental marketing application for approval of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for 12 years and older.

  • Price Action: PFE shares are down 0.38% at $39.75, and BNTX shares are down 0.47% at $129.77 during the premarket session on the last check Wednesday.

  • Photo via Wikimedia Commons

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article FDA Approves Pfizer/BioNTech's Bivalent COVID-19 Vaccine For Youngest Kids originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories